Clinical Research Coordinator I

Dartmouth-Hitchcock Health • Lebanon, NH

5d

About The Position

The Clinical Research Coordinator I works closely with research staff to support basic administrative clinical-trial tasks. The role has no supervisory responsibilities and works under the direct supervision of the Principal Investigator or designee. The coordinator learns and supports study operations, including subject management and regulatory activities, with substantial oversight. The position cannot perform tasks that state or local law requires a license to perform.

Requirements

• Bachelor's degree or an equivalent combination of education and experience.
• BLS certification within 30 days of hire.
• Human Subject Protection, Responsible Conduct of Research, and Good Clinical Practice certificates within 30 days of hire.
• Must not perform tasks that state or local law requires a license to perform.

Nice To Haves

• Previous research experience preferred.

Responsibilities

• May arrange and schedule required appointments.
• Learn and support study operations, including subject management and regulatory activities, under substantial oversight.
• Support subject management through visit preparation, Clinical Trial Management System (CTMS) data entry, scanning informed consents into the Electronic Medical Record (EMR), and other study data-entry needs.
• Assist with compiling and maintaining essential records and documents required by DHMC and sponsors in compliance with applicable standard operating procedures, including timely Institutional Review Board (IRB) submissions.
• Support the supervisor and IRB on regulatory and sponsor-related issues.
• Assist with accurate and timely sponsor communications about research-study status.
• Assist investigators with regulatory processes under supervisor direction.
• Maintain a basic, current understanding of IRB and D-HH institutional processes.
• Maintain and track on-site and off-site study-record storage; assist with data entry and accurate use of essential-document tracking systems.
• Assist with local and commercial IRB submissions, modifications, renewal applications, and study closeouts.
• Assist with scheduling and coordinating site visits, participate as assigned, and track action items through completion.
• Track essential regulatory documents in accordance with ICH Good Clinical Practice guidelines, including investigator CVs, medical licenses, CITI records, and clinical laboratory certifications.
• Adhere to ethical research principles and safeguards for human-subject protection, particularly for vulnerable populations, and prioritize participant safety.
• Use Electronic Data Capture (EDC) systems and other technologies and software required for study operations.
• Enter test results and other measures according to protocol and role; complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and according to protocol.
• Help investigate incomplete, inaccurate, or missing data and documents; follow SOPs for data quality assurance.
• Use standard processes, policies, and systems to protect data integrity, attribution, and security.
• Demonstrate professional guidelines and ethical standards for clinical research and complete all D-H and project-specific training.
• Assist with study administration, including document and supply management; maintain lab kits and regulatory and subject binders.
• May participate in manuscript or abstract development.
• Communicate appropriately in writing and orally with stakeholders; help coordinate communications among investigators, regulatory agencies, D-H stakeholders, and study participants to resolve problems.
• Perform other duties as required or assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level